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EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00041028
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 1, 2015
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of anticancer therapy. EF5 is a drug used in the measurement of oxygen in tumor tissue.

PURPOSE: Phase II trial to study the effectiveness of EF5 in assessing tumor response to anticancer therapy in patients who have stage I, stage II, or stage III non-small cell lung cancer.


Condition or disease Intervention/treatment Phase
Lung Cancer Drug: EF5 Other: flow cytometry Other: immunohistochemistry staining method Phase 2

Detailed Description:

OBJECTIVES:

  • Assess the frequency and degree of hypoxia as measured by etanidazole derivative EF5 binding in patients with stage I, II, or III non-small cell lung cancer.
  • Correlate hypoxia as measured by EF5 binding with potential serum/plasma markers and tissue markers of hypoxia in these patients.
  • Correlate hypoxia as measured by EF5 binding with tumor angiogenesis and apoptosis in these patients.
  • Correlate tumor perfusion with hypoxia in these patients.
  • Correlate tumor perfusion with microvessel density in tumor samples in these patients.
  • Determine the longevity of EF5 adducts in human lung tumors.

OUTLINE: Patients are stratified according to disease stage (stage I or II vs stage III vs no stage I-III determined after pathologic staging).

Within 24-48 hours prior to the planned surgical procedure, patients receive etanidazole derivative EF5 IV over 1-2.5 hours. Tumor hypoxia is then measured using an intraoperative Eppendorf needle electrode during surgical biopsy or resection. Tumor specimens are tested for EF5 binding using immunohistochemistry and flow cytometry.

Patients are followed at 4-6 weeks.

PROJECTED ACCRUAL: A total of 40-60 patients (20 with stage I/II disease, 20 with stage III disease, and 20 without stage I-III disease) will be accrued for this study.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Primary Purpose: Diagnostic
Official Title: Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-Small Cell Lung Cancer
Study Start Date : May 2002
Primary Completion Date : September 2007
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Frequency and degree of hypoxia as measured by EF5 binding at 24 to 48 hrs. after study drug infusion

Secondary Outcome Measures :
  1. Correlation of hypoxia with serum/plasma markers of hypoxia, tissue markers of hypoxia, tumor angiogenesis, apoptosis, tumor perfusion, and microvessel density at 24 to 48 hrs. after study drug infusion
  2. Longevity of EF5 adducts as measured by EF5 binding

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed or suspected non-small cell lung cancer (NSCLC)

    • If there is no histological or cytological documentation of NSCLC, must have at least a 75% probability of having NSCLC
    • Clinical or pathological stage I-III

      • Patients in whom pre-surgical staging has not definitively established stage IV disease are allowed
  • Tumor mass of ≥ 1.5 cm in maximum diameter must be present on CT scan and must be included in the planned surgical biopsy or resection
  • Must be planning to undergo a surgical staging or treatment procedure (including mediastinoscopy, wedge resection, lobectomy, or pneumonectomy)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC > 2,000/mm^3
  • Platelet count > 100,000/mm^3

Hepatic:

  • Bilirubin normal

Renal:

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after study participation
  • Able to hold breath for 27 seconds
  • No allergy to IV contrast dye
  • No history of grade III or IV peripheral neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041028


Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27705
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Investigators
Study Chair: Michael J. Kelley, MD Duke Cancer Institute
More Information

ClinicalTrials.gov Identifier: NCT00041028     History of Changes
Other Study ID Numbers: Pro00011318
DUMC-0041-M1RB00622
NCI-2310
CDR0000069437 ( Other Identifier: NCI )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 1, 2015
Last Verified: September 2006

Keywords provided by National Cancer Institute (NCI):
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms